Suraxavir marboxil and oseltamivir to prevent flu spread in hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts) are enrolled at a Beijing tertiary hospital. Room contacts are randomized 1:1:1 to receive placebo, suraxavir marboxil, or oseltamivir and are monitored for new influenza infection. The primary outcome is the rate of influenza infection among room contacts during the follow-up period. The trial includes patients aged 2 years and older and uses rapid antigen or nucleic acid testing on respiratory specimens to confirm infections.

Why it matters

Who can join: the full rules

1.Inclusion Criteria:

(1)Inclusion Criteria for Index Cases:

① Patients hospitalized at a participating medical institution.

* The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.

  * Age ≥ 2 years.

    * Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).

      (2) Inclusion Criteria for Room Contacts:

      ① Patients hospitalized at a participating medical institution.
* The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.

  ③ Age ≥ 12 years.
  * Expected to remain hospitalized for ≥ 72 hours.

    * Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.

      ⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1.

      3.Exclusion Criteria

      (1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:
      * Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.
* Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.

  * Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).

    * Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).

      * History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.

        * Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• China-Japan Friendship hospital, Beijing, Beijing
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yeming Wang, Ph.D.
• Email: wwyymm_love@163.com
• Phone: +86 84206264

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.